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Semi-quantitative Cough Strength Score (SCSS)

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ClinicalTrials.gov Identifier: NCT03031860
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Abdelrady S Ibrahim, MD, Assiut University

Tracking Information
First Submitted Date January 21, 2017
First Posted Date January 26, 2017
Last Update Posted Date January 8, 2018
Actual Study Start Date September 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2017)
Extubation outcome (success or failure), is the patient reintubate again or not and it's correlation with the level of Cough Strength Score [ Time Frame: within 6 hours postextubation ]
The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03031860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Semi-quantitative Cough Strength Score (SCSS)
Official Title Impact of Semi-quantitative Cough Strength Score as a Strong Predictor for Extubation Outcome in Head Trauma Patients: a Prospective Descriptive Study
Brief Summary Cough strength score will give true prediction of Extubation outcome
Detailed Description Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation. If they had completed an Spontaneous Breathing Trial (SBT) before extubation. To measure Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30° to 45°, measure SCSS, first. The investigator enhance the patient to cough with as much effort as, when the investigator disconnect the ventilator. The cough strength was scored from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The sample of this study include 80 head trauma patients from both sex of critically ill mechanically ventilated patient admitted to trauma Intensive Care Unit (ICU).
Condition Mechanical Ventilation
Intervention Other: Semiquantitative Cough Strength Score
Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score
Other Name: (SCSS)
Study Groups/Cohorts Not Provided
Publications * White AC. Long-term mechanical ventilation: management strategies. Respir Care. 2012 Jun;57(6):889-97; discussion 898-9. doi: 10.4187/respcare.01850. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 16, 2017)
80
Original Estimated Enrollment
 (submitted: January 24, 2017)
60
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The study included 80 adult male and female patients' their ages between 18-65 years admitted to trauma ICU with head trauma, on mechanical ventilation more than 24 hours and was ready to be weaned off from mechanical ventilation after successful spontaneous breathing trial and Glasgow Coma Scale (GCS) score > 8 before extubation

Exclusion Criteria:

• Patients who had undergone tracheostomy before extubation, GCS ≤ 8, chest trauma (ribs fracture and lung contusion) and patients with chronic chest disease (Chronic obstructive pulmonary disease, tuberculosis and cancer lung) were excluded from the study.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03031860
Other Study ID Numbers IRB0000871237
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abdelrady S Ibrahim, MD, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Principal Investigator: Eman M Aziz assiut university faculty of nursing
PRS Account Assiut University
Verification Date January 2018